United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spon

United States - English - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide capsules, usp is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules, usp is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide capsules, usp is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules, usp; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3­-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarke

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 5 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 20 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 100 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 140 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 180 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 250 mg - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

idt australia ltd - temozolomide, quantity: 100 mg - capsule, hard - excipient ingredients: lactose; sodium starch glycollate type a; silicon dioxide; stearic acid; tartaric acid; gelatin; purified water; sodium methyl hydroxybenzoate; sodium propyl hydroxybenzoate; sodium lauryl sulfate; allura red ac; titanium dioxide; shellac; isopropyl alcohol; propylene glycol; iron oxide black - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

Australia - English - Department of Health (Therapeutic Goods Administration)

idt australia ltd - temozolomide, quantity: 250 mg - capsule, hard - excipient ingredients: lactose; sodium starch glycollate type a; silicon dioxide; stearic acid; tartaric acid; gelatin; purified water; sodium lauryl sulfate; iron oxide black; titanium dioxide; shellac; isopropyl alcohol; propylene glycol; sodium methyl hydroxybenzoate; sodium propyl hydroxybenzoate - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.